BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Hybrid Stent Graft, Thoracic Aortic Lesion Treatment

    PMA: P210006 · Supplement: S016 · Decision Jan 29, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Hybrid Stent Graft, Thoracic Aortic Lesion Treatment
    Trade Name
    Thoraflex™ Hybrid
    PMA Number
    P210006
    Supplement Number
    S016
    Device Class
    FDA Class 3
    Product Code
    QSK
    Generic Name
    Hybrid stent graft, thoracic aortic lesion treatment
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 29, 2026
    Date Received
    December 30, 2025
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    an update to the lFU to include additional language regarding early imaging surveillance for patients at risk for intraluminal thrombosis

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QSK Hybrid Stent Graft, Thoracic Aortic Lesion Treatment